Unless they relied on more than passive reporting,
which is what VAERS is (i.e., conducted either post-marketing surveillance or a
study) and compared vaccinated to NEVER vaccinated, this question has not been
properly addressed. - SM
Findings From The Anthrax Vaccine Expert Committee (AVEC) Do Not
Suggest A High Frequency Of Adverse Events Associated With Anthrax
Vaccination
NEW YORK, NY -- May 3, 2002 -- Between March
1998 and March 2002, 525,000 US military personnel were vaccinated against
anthrax. In the case of an outbreak, this vaccine could be extended to
civilians, as occurred in December 2001. AVEC -- a civilian panel of
physicians and scientists set up to monitor the safety of the vaccination --
have published their findings in the April/May 2002 issue of
Pharmacoepidemiology and Drug Safety. The findings show that reports
submitted to the Vaccine Adverse Reporting System (VAERS) over a two-year
period did not indicate a high frequency or unusual pattern of serious
vaccine-related reactions.
Anthrax is a serious disease caused by the
bacterium Bacillus anthracis. It is of special concern because spores can
easily be weaponized. Recent illnesses and deaths in the US associated with
anthrax spores in the mail further underscore the grave potential this
bacterium has as an instrument of bioterrorism.
The Anthrax vaccine is made from a sterile
filtrate of a microaeorophilic culture of an attenuated, nonencapsulated,
nonproteolytic strain of B. anthracis. The culture filtrate is absorbed into
aluminium hydroxide to create the final vaccine, which is known as Anthrax
Vaccine Adsorbed (AVA). AVA is administered as a primary series of 6
subcutaneous injections followed by annual booster injections. Since
military vaccination programs were initiated in 1999 there have been many
circumstantial rumors about the safety of the vaccine. In an accompanying
editorial Neal Halsey, Director of the Institute for Vaccine Safety
comments, "The public must be confident that vaccines are made as safe as
possible in order to maintain the high levels of acceptance that are
necessary to control the disease." He adds, "this report should help address
and reduce many of these concerns."
AVEC reviewed and medically evaluated 602 of
reports adverse events submitted to VAERS. This was correlated with
information from the immunization records maintained by the Defense Medical
Surveillance System allowing the committee to profile adverse events with
respect to person, location, receipt of other drugs and vaccine amount.
Committee Chair and lead author John Sever
said, "a question of paramount interest was whether a review of this initial
set of 602 VAERS reports would find an excessive number of medically
important adverse events attributable to AVA." That was not the case. There
were no deaths among those reports and only 7 of 34 reported serious adverse
events were judged by the committee to fit the World Health Organization
(WHO) causality categories of probable or very likely/certain to be caused
by the vaccine.
Six were local injection site reactions, all of
which involved a period of hospitalization but resolved completely. They
were rated as very likely/certain consequences of vaccination. Furthermore
it appears that the local reactogenicity of this vaccine can be quite
substantial, since nearly half of the VAERS reports cited some degree of
local reaction. "A particularly significant finding is that some vaccines
with injection- site inflammation also experienced distal paresthesia," said
Sever. "We concluded that in some cases administration of the vaccine as a
subcutaneous injection in the region of the triceps apparently resulted in
direct trauma to the underlying ulnar nerve or delayed-onset compression
neuropathy due to localized inflammation. Subcutaneous injection of AVA over
the inferior deltoid could eliminate the risk of such injuries and is
recommended."
A tentative causality rating of probable was
assigned to a single systemic serious adverse event, a case of bronchiolitis
obliterans organising pneumonia (BOOP) in a person who experienced an
injection-site reaction and an unspecified diffuse rash after the first dose
of vaccine. One day after a subsequent dose, this person developed
progressive hives and shortness of breath that continued and was diagnosed
as BOOP. Cultures of bronchial samples for bacteria and fungi were negative,
as were serological assays for rubella, adenovirus, mycoplasma, RF, ANA and
ANCA. Some experts, including Neal Halsey, "do not believe the committee can
assign a causality rating of probable for BOOP because based upon the
information that was available for their review it was virtually impossible
to rule out all other possible infections and contributing factors that
could have caused this illness." However, John Sever points out that the
"objective of the committee was to look for signals that adverse events
which might be attributable to the vaccine are occurring at an elevated rate
and warrant further investigation. By assigning a tentative assessment of
causality we are not saying that the vaccine is responsible for this event,
but it should be subjected to a more extended study."
A focused survey of the reports, done in
response to concern that the anthrax vaccine might be associated with
increased risk of a chronic illness characterized by fatigue, sleep
disturbance, neurological complaints, cognitive dysfunction, and other
symptoms, found only 5 that described such a "multi-symptom syndrome" and
none of these appeared to be causally related to vaccination.
The authors conclude "none of the other
patterns found in this review of VAERS reports suggests that the absorbed
anthrax vaccine is unsuitable for certain subpopulations or that any
particular lot of the vaccine is unsafe."
Article: "Safety of Anthrax Vaccine" by John L.
Sever, Alan I. Brenner, Arnold D. Gale, Jerry M. Lyle, Lawrence H. Moulton,
David J. West, Pharmacoepidemiology & Drug Safety; April/May 2002; 11:3;
189-202 pp.
Editorial: "Anthrax Vaccine and Causality
Assessment from Individual Case Reports" by Neal A. Halsey,
Pharmacoepidemiology & Drug Safety; April/May 2002; 11:3; 185-187 pp.
The aim of Pharmacoepidemiology and Drug Safety
is to provide an international forum for the communication and evaluation of
data, methods and opinion in the emerging discipline of Pharmacoepidemiology.
The Journal publishes peer-reviewed reports of original research, invited
reviews and a variety of guest editorials and commentaries embracing
scientific, medical, statistical and legal aspects of pharmacoepidemiology
and post-marketing surveillance of drug safety.
All contents Copyright (c) 1995-2002 Doctor's Guide Publishing Limited. All
rights reserved.
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
